Senior Manager, Quality Engineering & Quality Assurance

Edwards Lifesciences Gruppe; Draper (UT); On-site; USD 180,000 - 230,000; Full time

Job summary

Edwards Lifesciences in Draper, UT, is seeking a Senior Manager of Quality Engineering & Quality Assurance to lead the Metals Manufacturing quality function. You will ensure the site quality system, quality control, and inspection activities support in-process and finished goods, with a focus on CAPA, audits, and regulatory compliance.

Lead a QA team, partner with Manufacturing Operations, Supply Chain, and Engineering, and drive risk-based decisions using Six Sigma and LEAN methods.

Qualifications

• Bachelor's degree in related field (Materials, Chemical, Mechanical and/or Metals engineering).
• Experience in Quality Engineering or Quality Management within the medical device industry with demonstrated Product Quality decision-making.
• Demonstrated track record in management of technical and/or engineering disciplines in a dynamic Quality/Manufacturing environment.

Responsibilities

• Quality representative for metals during internal and external audits.
• Coordinate audit preparation, execution and action plans with Draper Quality Systems Management.
• Ensure metals organization meets Draper site quality objectives/plans and manage QA team activities.
• Develop a robust talent development plan aligned with department growth strategies.
• Identify opportunities and lead process changes to drive improvements.
• Manage CAPA and other quality project activities with timely deliverables.
• Collaborate cross-functionally to inspect in-process and finished goods and assemblies.

Skills

Quality leadership

Quality systems

Audit coordination

CAPA management

Six Sigma

Lean manufacturing

Cross-functional collaboration

Project management

Education

Bachelor's degree in Materials/Mechanical/Metals engineering

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.

Our Senior Manager, Quality Engineering & Quality Assurance position is a unique career opportunity that could be your next step towards an exciting future. The Senior Manager, Quality Engineering & Quality Assurance will manage the Metal Manufacturing team to ensure smooth and continuous operations of site quality system, quality control and assurance inspection for in process and finished goods. Oversee process audits and final product release documentation. Advise and facilitate failure investigations, compliance methodologies for manufacturing of Metal Components. Manage team with activities that focus on implementing and optimizing quality engineering practices while ensuring a culture of quality and compliance with global regulatory requirements.

What You'll Make an Impact

• Quality representative for Metals associated with internal and external audits.
• Coordinate with Draper Quality Systems Management for audit preparation, execution and action plans.
• Ensure Metals Organization executes to Draper site quality objectives/plans Manage supervisors and/or oversee the work of assigned quality assurance team within own function, one or more production line or projects.
• Develop a robust talent development plan in alignment with functional growth strategies of the department.
• Identify opportunities and lead the implementation of changes to drive improvements.
• Manage quality assurance project activities (e.g., CAPA) with the accountability for successful completion of all deliverables to the business within established schedule, scope and quality objectives including training, approvals, and system effectiveness.
• Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional groups.
• Collaborate with cross-functional groups to manage inspection of in-process and finished goods, assemblies and components including proper implementation.
• Negotiate solutions with cross-functional groups (e.g., Manufacturing Operations, Supply Chain, and Engineering) for continuous improvement.
• Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design on new products and/or processes.
• Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups.
• Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities.
• Develop a robust talent development plan in alignment with functional growth strategies of the department.
• Provide technical guidance to cross-functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity.
• Collaborate with Campus Model shared services to support Draper Metals Organization.

What You'll Need (Required)

• Bachelor's degree in related field related experience in Materials, Chemical, Mechanical and/or Metals engineering.
• Experience in Quality Engineering or Quality Management within the medical device industry with demonstrated Product Quality decision-making, or equivalent work experience based on Edwards' criteria.
• Demonstrated track record in management of technical and/or engineering disciplines in a dynamic Quality/Manufacturing Environment.

What Else We Look For (Preferred)

• Technical quality leadership experience supporting metals manufacturing, metal components, or precision-manufactured components.
• Experience supporting commercial production quality for processes such as machining, forming, chemical processing, laser cutting, tubing, nitinol, or other metal component manufacturing processes.
• Demonstrated experience leading both Quality Engineering and Quality Assurance functions, including oversight of NCRs, CAPAs, TMVs, inspection readiness, product release, and quality metrics.
• Experience managing Supervisors and associated direct and indirect manufacturing inspection and/or testing resources.
• Experience managing or partnering closely with inspection, quality control, and manufacturing operations teams to ensure in-process and finished goods meet quality, compliance, and release requirements.
• Medical Device external audit leadership experience.
• Proven ability to serve as a quality representative during internal, notified body, FDA, customer, or external regulatory audits, including audit preparation, execution, response, and action plan management.
• Strong working knowledge of applicable medical device quality system and regulatory requirements, including FDA Quality System Regulation, ISO 13485, GMP, and global quality standards.
• Experience using quality engineering tools and statistical methods such as process capability, statistical process control, FMEA, DOE, test method validation, root cause analysis, Lean, and Six Sigma.
• Demonstrated ability to lead technical quality investigations, drive risk-based decision-making, and implement sustainable corrective and preventive actions in a high-volume or complex manufacturing environment.
• Experience developing and using quality metrics, management review inputs, and operational dashboards to monitor trends, communicate risks, and drive continuous improvement.
• Certified Quality Engineer, Six Sigma Black Belt, Lean certification, or equivalent quality/manufacturing certification.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.